The Recall Desk
ModerateFDA (Drugs)·D-0408-2015·Announced 2015-03-18

Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

Micro Labs USA Inc. is recalling Simvastatin Tablets, 40mg, because the product failed a known impurity specification. The recall affects 13,488 bottles distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. Given the nature of the impurity failure, a score of 2 (Moderate) is appropriate as it is a voluntary precautionary recall for a specification failure without reported illness.

Plain-English summary

Micro Labs USA Inc. is recalling Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles. The recall was initiated because the product failed a known impurity specification. The affected product is manufactured by Micro Labs Limited in India for Micro Labs USA Inc. in Princeton, NJ.

The recall involves 13,488 bottles of the medication. The specific lot number is STDG010, with an expiration date of 3/2015. The product was distributed nationwide.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
Manufacturer
Micro Labs Usa, Inc S
Category
Drug — Prescription Medication
Hazard
Affected units
13,488

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: STDG010
  • Exp 3/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Micro Labs Usa, Inc S under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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